Trial · NCT00313014
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
NCT00313014, Phase 3, Terminated, Purdue Pharma LP; results first posted 2010-09-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain. Trials, record NCT00313014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00313014
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
- NCT number
- NCT00313014
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 660 participants, actual
- Lead sponsor
- Purdue Pharma LP
- Conditions
- Back Pain Lower Back Chronic
- Interventions
- Buprenorphine, Buprenorphine, Oxycodone Immediate-Release
- First posted
- 2006-04-11
- Last updated
- 2012-09-03
- Results first posted
- 2010-09-29
- Limitations and caveats
- BUP3015 was terminated early due to administrative reasons unrelated to efficacy or safety.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Last 24 hours score at weeks 4, 8, 12 of the double-blind phase | Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine) |
| Secondary | Mean Daily Number of Supplemental Analgesic Tablets | Double-blind phase (84 days) | The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase |
| Secondary | Oswestry Disability Index (ODI) Score (V 2.0) | Weeks 4, 8, 12 | The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.) |
| Secondary | The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. | Weeks 4, 8, 12 of the double-blind phase | The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath). Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Last 24 hours score at weeks 4, 8, 12 of the double-blind phase | Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | units on a scale | MEAN |
| SECONDARY | Mean Daily Number of Supplemental Analgesic Tablets | Double-blind phase (84 days) | Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | tablets | MEAN |
| SECONDARY | Oswestry Disability Index (ODI) Score (V 2.0) | Weeks 4, 8, 12 | Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | units on a scale | MEAN |
| SECONDARY | The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12. | Weeks 4, 8, 12 of the double-blind phase | Full Analysis Population (N = 660) consisted of subjects who were randomized and received at least 1 dose of double-blind study drug. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind BTDS 5 | Screening | 6.36 | Standard Error 0.075 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind BTDS 20 | Screening | 6.46 | Standard Error 0.084 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind Oxycodone Immediate-Release | Screening | 6.46 | Standard Error 0.079 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind BTDS 5 | Prerandomization | 2.84 | Standard Error 0.075 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind BTDS 20 | Prerandomization | 2.91 | Standard Error 0.075 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind Oxycodone Immediate-Release | Prerandomization | 2.74 | Standard Error 0.074 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind BTDS 5 | Week 4 | 3.79 | Standard Error 0.149 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind BTDS 20 | Week 4 | 3.40 | Standard Error 0.128 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind Oxycodone Immediate-Release | Week 4 | 3.14 | Standard Error 0.125 | units on a scale |
| Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12. | Double-blind BTDS 5 | Week 8 | 3.83 | Standard Error 0.162 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Double-blind BTDS 5 | 221 | |
| Overall Study | STARTED | Double-blind BTDS 20 | 219 | |
| Overall Study | STARTED | Double-blind Oxycodone Immediate-Release | 220 | |
| Overall Study | COMPLETED | Double-blind BTDS 5 | 128 | |
| Overall Study | COMPLETED | Double-blind BTDS 20 | 146 | |
| Overall Study | COMPLETED | Double-blind Oxycodone Immediate-Release | 159 | |
| Overall Study | NOT COMPLETED | Double-blind BTDS 5 | 93 | |
| Overall Study | NOT COMPLETED | Double-blind BTDS 20 | 73 | |
| Overall Study | NOT COMPLETED | Double-blind Oxycodone Immediate-Release | 61 |
Source ClinicalTrials.gov
Adverse events240
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Double-blind BTDS 5 | 18 | 221 | |
| other | Nausea | Gastrointestinal disorders | Double-blind BTDS 20 | 27 | 219 | |
| other | Nausea | Gastrointestinal disorders | Double-blind Oxycodone Immediate-Release | 18 | 220 | |
| other | Nausea | Gastrointestinal disorders | Open-label Run-in Period, BTDS 10/20 | 174 | 1,160 | |
| other | Constipation | Gastrointestinal disorders | Double-blind BTDS 5 | 7 | 221 | |
| other | Constipation | Gastrointestinal disorders | Double-blind BTDS 20 | 14 | 219 | |
| other | Constipation | Gastrointestinal disorders | Double-blind Oxycodone Immediate-Release | 14 | 220 | |
| other | Constipation | Gastrointestinal disorders | Open-label Run-in Period, BTDS 10/20 | 46 | 1,160 | |
| other | Vomiting NOS | Gastrointestinal disorders | Double-blind BTDS 5 | 5 | 221 | |
| other | Vomiting NOS | Gastrointestinal disorders | Double-blind BTDS 20 | 11 | 219 |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Double-blind BTDS 5 | ||
| Total, all-cause mortality | Double-blind BTDS 20 | ||
| Total, all-cause mortality | Double-blind Oxycodone Immediate-Release | ||
| Total, all-cause mortality | Open-label Run-in Period, BTDS 10/20 | ||
| Total, other adverse events | Double-blind BTDS 5 | 54 | 221 |
| Total, other adverse events | Double-blind BTDS 20 | 118 | 219 |
| Total, other adverse events | Double-blind Oxycodone Immediate-Release | 93 | 220 |
| Total, other adverse events | Open-label Run-in Period, BTDS 10/20 | 389 | 1,160 |
| Total, serious adverse events | Double-blind BTDS 5 | 6 | 221 |
| Total, serious adverse events | Double-blind BTDS 20 | 7 | 219 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21807566 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00313014
GET https://conductscience.org/api/trials/v1/NCT00313014/results?page=2